Kornimate/medical-research-clean huggingface dataset:
leptin and cytokines in diabetic pregnancy - physiologic or pathogenic role

Conditions: Gestational Diabetes Mellitus; Preeclampsia; Placental Hypoxia

Summary: leptin, a circulating hormone expressed abundantly in adipose tissue, has been reported to be a satiety factor. in addition, it has been shown to increase during pregnancy in maternal blood, parallel to increase in body fat mass, to correlate with fetal body weight gain and to fall down to basal levels after delivery. little is known about leptin levels in pregnant women with preexisting or gestational diabetes and their relationship with fetal and postnatal growth and perinatal complications. therefore, the proposed study aims to understand and characterize the role of leptin in gestational diabetes mellitus as well as the relationship between leptin, cytokines and the pathophysiological complications during diabetic pregnancy. specifically, we will evaluate 60 pregnant women both in germany and in israel and evaluate serum levels and mrna of leptin, cytokines (inflammatory as well as th1 and th2) and correlate them to maternal changes of body weight and birth weight in women of various degrees of glucose tolerance and with various degrees of metabolic control during pregnancy; relationship between serum and umbilical cord vein concentrations of leptin, cytokines and metabolic variables; placental expression of leptin, leptin receptor, selected cytokines, glut1 and 4 and relationship to leptin in serum and umbilical cord plasma; comparison between all above parameters of german and israeli pregnant women. the results of this new and systematic study will shed light on the role of leptin and cytokines in the development of glucose disturbances during pregnancy and the perinatal outcome of women with gestational or preexisting diabetes mellitus.


Eligibility criteria:
inclusion criteria: random glucose challenge test (gct): 50 g of glucose are orally given at any time of the day. the results are considered as positive if the capillary blood glucose concentrations 1 hour after the load are \>130 mg/dl. those with normal results serve as control group exclusion criteria: -
caregivers of children with repaired esophageal atresia-tracheoesophageal fistula

Conditions: Dysphagia; Quality of Life

Summary: children with esophageal atresia and tracheoesophageal fistula (ea-tef) may experience feeding and swallowing difficulties, which result in stressful interactions between children and caregivers, and potentially impact the concerns of caregivers. the aim of this study was to assess concerns of caregivers of children with ea-tef related to feeding-swallowing difficulties.

children with repaired esophageal atresia-tracheoesophageal fistula (ea-tef) experience some degrees of feeding and swallowing difficulties feeding and swallowing difficulties cause aspiration-induced recurrent pneumonia, malnutrition, dehydration and stressful interactions with their caregivers. there is lack of knowledge regarding the concerns of caregivers of children with ea-tef related to feeding and swallowing disorders.therefore, the aim of this study was to assess concerns of caregivers of children with ea-tef related to feeding-swallowing difficulties.

Eligibility criteria:
inclusion criteria: * having a child with ea-tef * having a child with swallowing disorders aged between 6 months-18 years exclusion criteria: * having a child without swallowing disorders
the efficacy and safety of ramosetron in patients undergoing off pump coronary artery bypass surgery

Conditions: Coronary Artery Bypass Graft Triple Vessel; Hypotension

Summary: the purpose of this study is to assess the effects of ramosetron on corrected qt interval in patients undergoing off pump coronary artery bypass surgery.


Eligibility criteria:
inclusion criteria: * elective off-pump coronary artery bypass graft surgery exclusion criteria: * emergency operation * preoperative use of any inotropics or mechanical assist device * severe liver disease (\>child class ii) * dialysis dependent renal failure * left ventricular ejection fraction \<30 % * combined major surgery like carotid endarterectomy * previous allergy history to any 5-hydroxytryptamine type 3 (5-ht3) antagonist * preoperative qt prolongation ( 500 \>msec) or arrhythmia
multimodal analgesic protocol to moderate acute pain

Conditions: Pain, Post-operative

Summary: with a prospective, observational study assess post-surgery pain levels and patient's use of opioids and other analgesic drugs to moderate pain following third molar surgery.

specific aims using the unc surgery clinic multi-modal protocol of drugs/dosages to control acute pain after third molar surgery assess each post-surgery day(psd) the patient reported 1. pain levels post-surgery as recorded by likert-type and gracely scales 2. quality of life(qol) outcomes for lifestyle and oral function 3. number of opioid doses taken by subject-patients 4. number of nsaid and acetaminophen doses taken by subject-patients.

Eligibility criteria:
inclusion criteria: * asa i,ii at least two lower 3rd molars scheduled for removal exclusion criteria: * patient being treated for opioid addiction/abuse including having rx for suboxone, methadone
identification of genomic changes in families having multiple members with tumors

Conditions: Glioma

Summary: this study will compare genomic alterations between the parents and the patients with high-grade glioma.

genomic changes leading to the formation of brain tumors are slowly being discovered. despite advances in genomic technology, much analysis is hindered by the lack of control samples that could better delineate genomic alterations leading to disease. the ideal genomic control would be the genetic material of the parents of afflicted individuals. the researchers propose to then compare the genomic material from parents of siblings, both of whom have a diagnosis of a high-grade glioma. additionally, the researchers will then compare the genomic alterations between the parents and the patients. this analysis will provide an unprecedented insight into genomic level changes that take place between parents and patients that resulted in the formation of a high-grade glioma.

Eligibility criteria:
inclusion criteria: * 18 years or older. * family history of brain tumor in first degree relative exclusion criteria: * less than 18 years

Keywords: brain tumor
changes in cerebral oxygenation studies during laparoscopy procedure

Conditions: Increase in Intra-abdominal Pressure; Increase in Intracranial Pressure (ICP); Laparoscopy; Cerebral Perfusion and Oxygenation

Summary: the motivation results from the fact, that an intra-abdominal pressure is correlated with cerebral perfusion, in a mechanism of reducing venous outflow. moreover, elevated intra-abdominal pressure leads to increase in intracranial pressure and decrease of cerebral perfusion pressure. the main aim of the study was to investigate an influence of increase in intra-abdominal pressure on cerebral oxygenation measured with the use of non-invasive optical technique.

the investigators applied time resolved near infrared spectroscopy device in order to estimate changes in hemoglobin concentration in a brain during gynecological procedure that involves laparoscopy. the optodes were positioned on a forehead on left and right hemisphere. the measurements were carried out during whole medical procedure, including anesthesia, start and stop of insufflation of abdominal cavity with carbon dioxide (co2), surgical procedure, release of co2 and waking up a patient. in those studies the special emphasis was put on a period of insufflation of abdominal cavity with co2.

Eligibility criteria:
inclusion criteria: * laparoscopic procedure exclusion criteria: * no consent

Keywords: intra-abdominal pressure intra-cerebral pressure laparoscopy brain perfusion brain oxygenation time-resolved near infrared spectroscopy
safety study of intravitreal ebi-031 given as a single or repeat injection to subjects with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the purpose of the study is to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of up to 3 dose levels of ebi-031 given as an intravitreal injection in subjects with diabetic macular edema. there are two arms to the study, a single dose arm (1 dose) and a repeat dose arm (1 dose each month for 3 months). eligible subjects will initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3 dose levels. safety will be assessed over the 28 days after the single dose prior to moving to the next higher dose level. once all subjects in the single dose arm have been dosed with ebi-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat dose arm. subjects in the repeat dose arm will receive one dose each month for 3 months and will be assessed for safety. escalation to the next higher dose will occur once it is determined safe to proceed to the next dose level. six subjects will be dosed at each of the 3 dose levels.


Eligibility criteria:
inclusion criteria: * give written voluntary informed consent and any authorizations required by local law * have a diagnosis of type 1 or 2 diabetes mellitus * have decreased vision determined primarily to be the result of dme in the study eye * mean central foveal thickness on spectral domain ocular coherence tomography (sd-oct)\> 325 in the study eye within 2 weeks of dosing * have best corrected early treatment of diabetic retinopathy study (etdrs) letter score of \ 19 (\~20/400) in the study eye within 2 weeks of dosing. exclusion criteria: * female that is pregnant and lactating * any prior history of anti-interleukin 6 (anti-il-6) treatment, for example: tocilizumab, sirukumab, sarilumab, olokizumab * any concurrent biologics for immune disease such as anti-tumor necrosis factor (tnf): enbrel (etanercept), humira (adalimumab), remicade (infliximab); an anti-interleukin 12 (anti-il-12): stelara (ustekinumab); or an anti-interleukin 1 (anti-il-1): kineret (anakinra), ilaris (canakinumab), arcalyst (rilonacept). * unstable, uncontrolled diabetes defined as hemoglobin a1c (hba1c)≥10.5% within 3 months prior to dosing of ebi-031 * received intravitreal anti-vascular endothelial growth factor (anti-vegf) such as eylea (aflibercept) within 8 weeks, lucentis (ranibizumab) and avastin (bevacizumab) within 4 months prior to ebi-031 * significant renal disease, liver disease, or acute congestive heart failure * history of myocardial infarction (mi), stroke, or transient ischemic attack (tia)
a study of the neovista ophthalmic system for the treatment of subfoveal cnv associated with wet amd in patients that require persistent anti-vegf therapy

Conditions: Age Related Macular Degeneration

Summary: the objective of the meritage trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (cnv) associated with wet age-related macular degeneration (amd) in patients that require persistent injections of anti-vegf therapy to maintain an adequate response to treatment.

therapeutic advances in the arena of neovascular age-related macular degeneration (amd) have provided multiple treatment options for the disease. brachytherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. treatment with radiotherapy and anti-vegf compounds is a promising approach to treating amd. the current treatment for neovascualar amd involves multiple injections over an indefinite period of time. this trial will evaluate whether treatment with brachytherapy can reduce or eliminate the need for continued injections.

Eligibility criteria:
inclusion criteria: * subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to amd, with a total lesion size (including blood, scarring, and neovascularization) of \< 12 total disc areas (21.24 mm2) and a gld ≤5.4 mm. * subjects must have completed anti-vegf induction treatment, defined as the first 3 months of treatment. following the induction period, subjects must have required at least 5 additional injections of avastin or lucentis in the 12 months preceding enrollment, or 3 additional injections of avastin or lucentis in the 6 months preceding enrollment, given on an as needed basis. subjects may have previously received macugen, although must meet the criteria above for lucentis or avastin. * subjects must be age 50 or older exclusion criteria: * subjects with prior or concurrent subfoveal cnv therapy with agents, surgery or devices (excluding macugen, avastin, or lucentis) including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, intravitreal or subretinal steroids, and transpupillary thermotherapy (ttt) * subjects who underwent previous radiation therapy to the eye, head or neck * subjects who have been previously diagnosed with type i or type ii diabetes mellitus. subjects that do not have a documented diagnosis, but have retinal findings consistent with type i or type ii diabetes mellitus.

Keywords: brachytherapy epirad macular degeneration ranibizumab
autopsy follow-up of subjects previously imaged with florbetapir f 18 (18f-av-45) pet in trial 18f-av-45-a07

Conditions: Alzheimer's Disease

Summary: this study is designed to test the relationship between measurements of brain amyloid using florbetapir f 18 pet imaging and true levels of amyloid plaque density as measured by histopathological assessment. the study will address the following specific aims: 1. to expand the number of subjects included in the a07 (nct00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir f 18 pet scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort). 2. to determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir f 18 pet scan (aβ+ or aβ-) versus the final blinded neuropathological assessment made at autopsy.


Eligibility criteria:
inclusion criteria: subjects are enrolled in this study if they: * met entrance criteria and were enrolled and imaged in trial 18f-av-45-a07 (nct00857415) * gave informed consent for the 18f-av-45-a07 (nct00857415) study procedures and brain donation consistent with the legal requirements of the state in which they are enrolled and the state in which they die * consent to participate in the 18f-av-45-a16 (nct01447719) extension protocol, if required by the irb * reconfirm their consent to a research brain autopsy, if required by the irb.
the establishment and application of the new labor progress centered system of reducing cesarean section rates in china

Conditions: Pregnancy Complications; Postpartum Hemorrhage

Summary: 1. to describe the average labor curve and establish new labor progression standards. 2. cesarean section rates: based on big data, the investigator will introduce the international advanced robson class method and identify the appropriate level of cesarean section rate for each type population. 3. establishment of "chinese maternal-fetal medical collaboration network" and app to promote natural childbirth.

1. to describe the average labor curve and establish new labor progression standards. the investigator will investigate the current characteristics of obstetric population and the labor progression with obstetric intervention in china. the investigator compare the different effects of traditional labor progression management model, new labor progression management model and active labor progression management model on labor outcomes. based on the best outcomes of maternity and infants, the investigator will establish and modify new labor progression which is suitable for chinese. 2. cesarean section rates: based on big data, the investigator will introduce the international advanced robson class method and identify the appropriate level of cesarean section rate for each type population.the investigator compare cesarean section rates of different level hospitals and evaluate the effects of reducing cesarean section rates. the investigator also analyze the risk factors of cesarean section rates of the ten robson classification, which will provide basis for reducing cesarean section rates under the new strategy. 3. establishment of "chinese maternal-fetal medical collaboration network" and mobile application software (app) to promote natural childbirth: the investigator establish perinatal data center using the hospital information system (his) system of hospital. the investigator predict the cesarean section rates and relative factors using the robson classification method, and propose the new strategy of reducing cesarean section rates. meanwhile, the investigator develop the quality management system toolkit which can help clinicians standardize behavior and improve obstetric safety.

Eligibility criteria:
inclusion criteria: 1. chinese pregnant women 2. singleton 3. head position 4. 37 weeks + 0 day - 41weeks + 6 days 5. primipara 6. low-risk pregnancy 7. vaginal delivery willingness 8. vaginal cervix \<7 cm after labor exclusion criteria: 1. multiple pregnancy 2. non-head position 3. stillbirth 4. selective cesarean section 5. prenatal cesarean section 6. age \<18 years 7. previous childbirth history 8. pregnancy complications 9. important fetal malformations.
the impact of individual-based discharges from acute admission units to home

Conditions: Patient Discharge

Summary: the present non-blinded randomized controlled trial (rct) investigates the effect of a comprehensive discharge model in adult medical patients discharged directly home from an acute admission unit (aau). in addition, eligible patients should have, at least, one hospital admission 12 months prior to index hospitalization and be discharged for further follow-up by general practitioner, home care nursing or in an out-patient clinic. the model consists of 3 main steps during the short term stay in the aau. first, patients are screened for pre-hospital conditions that might have contributed to the index hospitalization i.e. functional ability, ongoing treatment including drug treatment, need for additional assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses, walker. second, at point of discharge there will be a thorough assessment of the discharge plan focusing on the patients' comprehension of the discharge plan as well as accept of the suggested treatment and follow-up. third, within 2 days after discharge the patient will receive a discharge letter by email or postal mail written in plain language and repeating the information provided in the discharge summary to the general practitioner. subsequently, the patient will receive a telephone follow-up from the research nurse addressing the content in the discharge letter and possible unresolved issues related to the index hospitalization. patients in the control group receives the usual discharge practice in the aau which does not include a discharge letter to the patient and telephone follow-up after discharge. the primary endpoint is number of readmissions within 72 hours and 30 days after discharge. secondary endpoints are healthcare service utilization within 30 days after discharge this includes number of contacts to general practitioner, out-of-hours physicians, emergency departments and if possible visits by home care nurses. additionally, quality-of-life measured 30 days after discharge by the questionnaire eq5d and patient experience of the discharge process is measured 7 days after discharge by a danish national patient experience survey - serves as secondary endpoints.


Eligibility criteria:
inclusion criteria: * medicine diagnosis * discharged directly to home * 1 admission during the last 12 months * having a planned follow-up after discharge (general practitioner, home care nurse, out-patient clinic) * read and understand danish exclusion criteria: * demented, living outside the council of aarhus, included in a rival study

Keywords: discharge acute admission unit randomized controlled trial
insti® hcv (hepatitis c virus) antibody self-test contrived result interpretation

Conditions: Hepatitis C

Summary: the purpose of this interpretation assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a hepatitis c virus (hcv) self-test (hcvst) device, without product familiarization \[demonstration\].

the intent of this study was to collect data regarding the result interpretation of contrived results of insti hcv st. the contrived test devices refers to mock test devices pre-made by biolytical laboratories inc. each contrived/mock test device was assigned to an id number to be randomly provided to the participants. primary objectives were to document and record the following: •successful interpretation of contrived test results using mock test devices (strong positive, weak positive, negative and a range of invalid results). depending on the device being evaluated participants received a contrived insti® hcv antibody self test membrane unit. participants were asked to interpret "mock" results \[read contrived device results using the reference chart in the instructions for use (ifu)\]. participants were recruited from the ezintsha research site which was a low-prevalence area and the yeoville harm reduction site which was a high-prevalence area in the city of johannesburg in the republic of south africa. for the purposes of this assessment, the participant population was the general population. the participants did not have any experience in conducting any rapid diagnostic self-test using standard test kits, nor were they familiar with the prospective hcvst devices prior to entering into this mock result interpretation assessment.

Eligibility criteria:
inclusion criteria: * understands and sign the written informed consent form * able to complete the required testing on the allocated testing day\[s\] * able to speak/read english * ≥18 years of age * provide a level of education (minimum grade 7) exclusion criteria: * does not meet the inclusion criteria * a practicing medical healthcare professional \[doctor, nurse or counsellor that performs testing with rapid tests\] * has used blood-based rdt for self-testing previously, either hiv or hcv * any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the mock result interpretation assessment, consent form and questionnaire etc. or bias the outcome

Keywords: hepatitis c self test hepatitis c rapid test hcv antibody insti hcv self test
randomised placebo-controlled duloxetine-referenced efficacy and safety study of 2.5, 5 and 10 mg of vortioxetine (lu aa21004) in acute treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * mde as primary diagnosis according to dsm-iv-tr criteria (classification code 296.xx) * moderate to severe depression * current mde duration of at least 3 months exclusion criteria: * any current psychiatric disorder other than mdd as defined in the dsm-iv tr * any substance disorder within the previous 6 months * female patients of childbearing potential who are not using effective contraception * use of any psychoactive medication 2 weeks prior to screening and during the study other protocol-defined inclusion and exclusion criteria may apply.

Keywords: major depressive disorder placebo-controlled active reference multicenter study randomised study acute treatment